A Question of Intent: A Great American Battle with a Deadly Industry.

A Question of Intent David Kessler PublicAffairs http://www.publicaffairsbooks.com [phone] 492pp., $27.50

David Kessler--physician, lawyer, and commissioner of the Food and Drug Administration (FDA) from 1990 to 1997--is a hero. Even before taking on Big Tobacco, he had transformed the FDA from a sclerotic bureaucracy into an effective and feared consumer protection agency.

His seizure of 24,000 cartons of "fresh" Citrus Hill orange juice, which really had been made from concentrate, ended an "anything goes" era in food labeling. Because he insisted that uniform, accurate, and understandable nutrition labels appear on all food packages, consumers can compare the nutritional values of different products and choose healthy diets.

Kessler will probably be best remembered for his battle with the tobacco industry. Regulating cigarettes, a product that contains an addictive drug and kills over 400,000 Americans each year, would seem to be a normal function for a drug regulatory agency. But none of Kessler's predecessors was willing to take on the task. Kessler did.

In A Question of Intent, he gives readers a behind-the-scenes look at the political, legal, and investigative struggles in the battle against the tobacco industry. The writing is clear and succinct, scenes and characters come alive, and drama builds.

Kessler acknowledges in the book that he was reluctant at first to take on the tobacco industry. For good reason. The Surgeon General's report linking cigarettes with lung cancer appeared in 1964, and hundreds of scientific studies showing that they cause a wide variety of other diseases appeared every year thereafter. His predecessors' failure to act could be construed as a concession that FDA jurisdiction was somehow lacking.

Then there was the question of what the agency should do if it were able to assert jurisdiction over tobacco products. Using the usual standard, tobacco products would have to be banned, since their benefits did not exceed their adverse effects. But no one, and least of all Kessler, thought that banning cigarettes was a good idea. Was there any viable toehold on the slippery slope from asserting FDA jurisdiction to prohibiting cigarettes altogether?

And, of course, there was the tobacco industry. When Joseph Califano Jr., Jimmy Carter's secretary of Health, Education, and Welfare, tried to take on Big Tobacco in the late 1970s, the industry lobbied Carter to fire him. He did. Other than former Surgeon General C. Everett Koop, no other high-profile government official had shown the slightest inclination to risk his or her own political destruction by angering the tobacco industry. Then came Kessler.

Stopping an epidemic

Federal law defines a drug as "a substance other than food intended to affect the structure or function of the body." Whether nicotine is a drug should therefore be a question of the manufacturer's intent.

Documents from the Cipollone v. Liggett Group, Inc. cigarette litigation include a 1972 memo from a senior scientist at Philip Morris, telling his colleagues to "think of the cigarette pack as a storage container for a day's supply of nicotine ... [and]... the cigarette as a dispenser for a dose unit of nicotine."

Other internal documents, as well as interviews with industry insiders, confirmed for Kessler that the industry had taken this and similar statements to heart.

So what could the FDA do? Thinking about the nature of nicotine yielded an answer. Nicotine keeps the consumer hooked, smoking long enough and frequently enough to allow the toxins in the tar to do their lethal work. Smokers overwhelmingly got hooked on nicotine as kids or teenagers; nonaddicted adults, by and large, knew better.

Kessler developed the notion that the epidemic of cigarette-caused addiction, disease, and death was really a pediatric issue because minors' immature "choices" set the process in motion. He found plenty of evidence to suggest that targeted marketing and the easy availability of cigarettes, despite laws in every state banning sales to minors, contributed to these "choices."

The FDA chief focused his proposed remedies on restricting advertising and closing illegal supply lines. He also discovered that the Safe Medical Devices Act of 1990 gave him more regulatory flexibility than drug laws did. The act allowed him to regulate cigarettes and smokeless tobacco products as nicotine delivery devices rather than ban nicotine as an inherently dangerous drug.

In 1997, Kessler left the FDA voluntarily to become dean of Yale University School of Medicine. Before doing so, he had documented the results of the FDA's massive investigation of the tobacco industry in a 700-page statement and obtained President Clinton's approval to assert jurisdiction over cigarettes and smokeless tobacco.(1) He also promulgated regulations that limited advertising aimed at young people and imposed restrictions on retail outlets to reduce sales to minors.(2)

Extraordinary ending

The most extraordinary part of Kessler's book is its conclusion. Recall the background. In June 1997, state attorneys general, private counsel representing a class of smokers, and the tobacco industry reached a global settlement that proposed legislation to confirm FDA jurisdiction over tobacco products. Unfortunately, that legislation also would provide virtual immunity for the tobacco industry from future lawsuits. A coalition of public interest organizations, in which ATLA played a major role, opposed the measure.

The immunity provision eventually was stripped from the bill. The tobacco industry ordered its army of lobbyists, which had originally been assembled to get the bill passed, to do an about-face and kill the bill. It died in the U.S. Senate in June 1998, and the FDA's jurisdiction over the industry died with it.

In March 2000, the U.S. Supreme Court overruled Kessler's conclusion that the FDA could regulate tobacco as a nicotine delivery device.(3) As a result, neither that agency nor any other federal agency can take action to stop the tobacco industry from continuing to addict about 1 million young adults every year.

What was Kessler's reaction? He had devoted several years of his life to establishing FDA jurisdiction over tobacco products. Was he furious at the coalition that opposed the immunity provisions for having ruined his life's work? Far from it. He writes in A Question of Intent that he too has "fiercely" opposed immunity for the tobacco companies and that litigation "has emerged as the strongest weapon to chip away at the power of the industry."

While he didn't begin the battle seeking to dismantle the industry, he writes, "it has become apparent that nothing else will work." He predicts, perhaps in an optimistic light, that the industry eventually will agree, under the pressure of litigation, to walk away from its domestic tobacco operations.

Kessler concludes that "whatever the challenges, the industry cannot be left to peacefully reap billions of dollars in profits, totally unrepentant, and without thought to the pain caused in the process. For that remains its intent."

Notes

(1.) Nicotine in Cigarettes and Smokeless Tobacco Is a Drug and These Products Are Nicotine Delivery Devices Under the Federal Food, Drug, and Cosmetic Act: Jurisdictional Determination, 61 Fed. Reg. 44619, 45318 (Aug. 28, 1996).

(2.) Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, 61 Fed. Reg. 44396, 44618 (Aug. 28, 1996).

(3.) Food & Drug Admin. v. Brown & Williamson Tobacco Corp, 529 U.S. 120 (2000).

Richard A. Daynard is a professor at Northeastern University School of Law in Boston and chair of the Tobacco Products Liability Project.